A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts General Hospital
- Study ID
- NCT03945721
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Residual Disease
- Triple Negative Breast Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Niraparib — DRUGNiraparib is a type of drug called a "PARP inhibitor", which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells by not allowing the cancer cells to repair its DNA damage or prevent DNA damage from occurring.
- Radiation Therapy — RADIATIONradiation therapy
Study Details
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Key Dates
- Start date
- Jul 11, 2019
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 21 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Niraparib* Niraparib will be administered orally on a daily basis * Radiation Therapy will be administered concurrently with Niraparib
Primary Outcome Measure
Maximum Tolerated Dose [ Time Frame: 10 weeks ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute/Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | - |
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